Cleared Traditional

COBB SPINAL ELEVATORS (K882068) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K882068 · Karlin Technology, Inc. · Orthopedic device
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Jun 1988
Decision
17d
Days
Class 2
Risk

K882068 is an FDA 510(k) clearance for the COBB SPINAL ELEVATORS. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Karlin Technology, Inc. (Marina Del Rey, US). The FDA issued a Cleared decision on June 3, 1988 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Karlin Technology, Inc. devices

Submission Details

510(k) Number K882068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1988
Decision Date June 03, 1988
Days to Decision 17 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 122d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWP Appliance, Fixation, Spinal Interlaminal

All 99
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K882068.
LUQUE SEGMENTAL SPINAL INSTRUMENTATION
K913561 · Zimmer, Inc. · Jan 1992
MODULOCK POSTERIOR SPINAL FIXATION
K902397 · Zimmer, Inc. · Nov 1990
MODULAR SPINAL FIXATION & LOCKING HOOK SPINAL ROD
K884688 · Synthes (Usa) · Feb 1989
EDWARDS SACRAL SCREW
K851935 · Zimmer, Inc. · Jun 1985
DEPUY SEGMENTALSPINAL SYSTEM
K810329 · Depuy, Inc. · Apr 1981
ARMSTRONG SPINAL APPLIANCE
K810224 · Howmedica Corp. · Feb 1981